Effectiveness and Efficiency of Two Models of Delivering Care to a Chronic Wound Population

• ClinicalTrials.gov Identifier: NCT00656383
• Recruitment Status: Completed
• First Posted: April 11, 2008
• Last Update Posted: November 20, 2015
• Sponsor: Queen's University
• Collaborators: The Ottawa Hospital; University of Ottawa
• Information provided by (Responsible Party): Dr. Margaret Harrison, Queen's University

Tracking Information

• First Submitted Date: April 7, 2008
• First Posted Date: April 11, 2008
• Last Update Posted Date: November 20, 2015
• Study Start Date: October 2000
• Actual Primary Completion Date: March 2004 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: April 10, 2008): Proportion in each study arm of ulcerated limbs completely healed at 3 months [ Time Frame: 3 months ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 10, 2008)

• Time to complete healing, ulcer size, and ulcer recurrence over 12 months [ Time Frame: 12 months ]
• Client function, pain and health-related quality of life [ Time Frame: 12 months ]
• Client and provider satisfaction [ Time Frame: 12 months ]
• Health services expenditure and utilization [ Time Frame: 12 months ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effectiveness and Efficiency of Two Models of Delivering Care to a Chronic Wound Population
• Official Title: Effectiveness and Efficiency of Two Models of Delivering Care to a Chronic Wound Population
• Brief Summary: Individuals referred to home care for leg ulcer management were randomized to nurse home visits (usual care) or nurse-run community clinics (intervention). The primary outcome will be the time to healing rates at three months. Secondary outcomes are: time to healing of all ulcers within the 12 month follow-up period, time to first recurrence of a healed ulcer, the number of weeks patients were free from ulcers, function, pain, and health related quality of life, client and provider satisfaction. We hypothesize that nurse-run neighborhood clinics result in better healing rates, more cost-effective care, and improved client and provider satisfaction than the home visiting model.

Detailed Description

The management of chronic wounds in the community is a pressing issue for home care authorities. The care of leg ulcers represents a considerable expense to the health care system. It has been estimated that the care of venous leg ulcers alone consumes 1% of the national health care budgets of the UK and France. A one-month prevalence study in the Ottawa Carleton region (pop. 750,000) revealed that 126 Community Care Access Centre Clients (CCAC - the regional health care authority) received over 1500 home nursing visits. During the course of a year this represents more than $600,000 in home nursing visits for this condition in just one Ontario region. There is evidence supporting effective wound management but this is not necessarily what patients receive. As well, appropriate evidence-based, efficient, community-based care must be supported by ready access to specialized facilities. Research from other countries suggest that reorganization of services which includes nurse-run clinic care near to home, evidence-based protocols, and enhanced linkages with secondary and tertiary services may result in improvements in healing rates and reductions in expenditures. These international studies provide optimism that with reorganization of care within the Canadian context we can deliver community services for improved outcomes. However, only with a rigorous evaluation of the effectiveness and efficiency can we understand if such changes in the Canadian context are beneficial.

Objective:

To evaluate the effectiveness and efficiency of two models of service delivery: traditional single service delivery model (home visiting) compared to nurse-led community clinics.

Research Questions:

1. What are the health outcomes (healing, function, plain and quality of life) for two models of care (nurse-run neighbourhood clinics vs. home care) for the population with leg ulcers?
2. What are health services utilization and expenditures associated with the two models of care?
3. What is client and provider satisfaction with the nurse-run neighbourhood clinics and home nursing care?
4. What are the barriers and supports to implementing neighbourhood leg ulcer clinics?

Study Design and Method:

A randomized health services controlled trial of nurse-run neighbourhood leg ulcer clinics (intervention) and home care (current practice) with a cost-effectiveness analysis. A repeated measures design will be used to assess healing and ulcer improvement, quality of life and patient satisfaction over time.

Outcome measures:

The primary outcome measure is the proportion of limbs healed by three months. Secondary outcome measures are: time to complete healing, ulcer size, ulcer recurrence, function, pain, quality of life, client and provider satisfaction.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Varicose Ulcer

Intervention

• Other: Clients randomized to nurse-led clinic
  Clients receive leg ulcer care in a nurse-led clinic; both groups are treated by the same health care providers using the same protocol
  Other Names:

  • Usual Care
  • Best Practice
  • Venous Leg Ulcer treatment
• Other: Clients receive leg ulcer care in their homes
  Clients receive leg ulcer care in at home; both groups are treated by the same health care providers using the same protocol
  Other Names:

  • Leg Ulcer Care
  • Usual Care
  • Best Practice

Study Arms

• Active Comparator: 1
  Client is randomized to receive leg ulcer treatment in the home
  Intervention: Other: Clients receive leg ulcer care in their homes
• Active Comparator: 2
  Client randomized to receive leg ulcer care in the clinic
  Intervention: Other: Clients randomized to nurse-led clinic

• Publications *: Harrison MB, Graham ID, Lorimer K, Vandenkerkhof E, Buchanan M, Wells PS, Brandys T, Pierscianowski T. Nurse clinic versus home delivery of evidence-based community leg ulcer care: a randomized health services trial. BMC Health Serv Res. 2008 Nov 26;8:243. doi: 10.1186/1472-6963-8-243.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 10, 2008): 401
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: March 2005
• Actual Primary Completion Date: March 2004 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

The client:

• Admission to home care for care of a venous leg ulcer (below the knee to the foot)
• Ability to travel to clinic
• No major contraindication for clinic care (eg not being able to leave an ill spouse, refusal, etc.)

Exclusion Criteria:

• Treatment is contraindicated
• The ulcer in question is not venous
• The client cannot travel outside the home or travel is impeded

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 90 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT00656383
• Other Study ID Numbers: MOP-42497
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Dr. Margaret Harrison, Queen's University
• Original Responsible Party: Dr. Margaret B. Harrison, Loeb Health Research Institute
• Current Study Sponsor: Queen's University
• Original Study Sponsor: University of Ottawa

Collaborators

• The Ottawa Hospital
• University of Ottawa

Investigators

• Principal Investigator: Margaret B Harrison, RN, PhD; The Ottawa Hospital
• Study Director: Ian D Graham, PhD; Clinical Epidemiology Unit, Ottawa Hospital-Civic Campus
• Study Director: Philip S Wells, PhD; The Ottawa Hospital
• Study Director: Susan VanDeVelde, PhD; Victorian Order of Nurses, Ottawa-Carleton Branch
• Study Director: Judith L Threinen, BSR, MHA; Ottawa-Carleton Community Care Access Centre
• Study Director: Donna I Nicholson, Dip O&A; Ottawa Carleton Community Care Access Centre

• PRS Account: Queen's University
• Verification Date: November 2015